About the job
The Regulatory Engineer ensures the company’s medical devices meet established requirements and standards, manages regulatory filing in various markets and collaborates closely with cross-functional teams to prepare regulatory technical documentation.
Responsibilities
Manage registration of commercial products in different markets including US and OUS.
Maintain applicable standards list and traceability between technical documents and applicable standards.
Hands-on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations (worldwide). Maintain Technical files for submission (CE, FDA and more).
Perform routine regulatory monitoring, and coordinate with Subject matter experts the impact analysis of new/updated standards.
Perform regulatory impact analysis of design change requests and manage Letter to File process
